DESCRIPTION: Currently under development is a novel optical probe for non-invasive characterization and monitoring of the biochemical and morphological changes in oral cavity epithelium leading to dysplasia and ultimately to invasive squamous cell carcinoma. Oral squamous cell carcinoma is a condition, which will kill approximately half of patients afflicted within five years of diagnosis and may leave surviving patients with severe aesthetic or functional compromises. Approximately 31,000 Americans develop oral cancer each year. Oral cancer progresses through a series of morphologic changes, which, if detected and treated early, can vastly improve prognosis and survival. Clinicians in the oral and Dental fields play an important role in early detection of oral cancer, and the current application seeks to develop a tool to aid these clinicians in accurate screening and diagnosis. During a previous Phase 1 SBIR effort, a fluorescence image guided optical coherence tomography (FIG-OCT) probe, capable of simultaneously acquiring and co-registering tissue autofluorescence and optical coherence tomography (OCT) images, was designed and built. Fluorescence imaging provides a highly sensitive and rapid means for oral cavity screening, while the ability of OCT to elucidate high-resolution sub-surface morphological features leads to a superior diagnostic technique with higher specificity than autofluorescence imaging alone. In a hamster model of oral cancer, it was successfully demonstrated that FIG-OCT resulted in a rapid and accurate technique for oral cancer screening. The current Phase 1 application presents plan to adapt this instrument into a form, which can be used, for preliminary clinical investigation in humans. PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE